CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
capecitabine +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Histologically or cytologically confirmed stage IV metastatic breast cancer (M1) or multiple sites of new clinically obvious metastatic disease
  • ✓Measurable disease OR non-measurable disease with MUC-1 antigen level >2x upper limit of normal and increased by 1.5x
  • ✓Must have documented MUC-1 antigen level (CA 15-3 or CA 27-29)
  • ✓At least 1 prior hormonal therapy for metastatic disease (estrogen receptor-positive patients only)
Key exclusion· 8
  • ✕Symptomatic brain or CNS metastases (treated and stable metastases allowed if radiotherapy completed ≥8 weeks before entry)
  • ✕Congestive heart failure, symptomatic coronary artery disease, uncontrolled cardiac arrhythmia, myocardial infarction within 12 months, or other clinically significant cardiac disease
  • ✕Uncontrolled nausea, vomiting, diarrhea, or lack of physical integrity of upper GI tract, or malabsorption syndrome
  • ✕Prior severe reaction to fluoropyrimidines or known sensitivity to fluorouracil or dihydropyrimidine dehydrogenase deficiency

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00107276
NCT00107276Phase 2Completed
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Phase II Trial of Simple Oral Therapy (Continuous Oral Cyclophosphamide and Capecitabine) in Patients With Metastatic Breast Cancer

SWOG Cancer Research Network·interventional·Posted Apr 6, 2005·Updated Jul 18, 2013

In Brief

A Phase 2 clinical trial evaluating capecitabine and cyclophosphamide for Breast Cancer. Completed, enrolled 112 participants across 145 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one chemotherapy drug may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cyclophosphamide together with capecitabine works in treating women with stage IV breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 6, 2005
Enrollment StartAug 1, 2005
Primary CompletionMar 1, 2008
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 21.2 years ago

Interventions

capecitabinedrug

cyclophosphamidedrug